Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019577

Enrollment

Registered

2009-11-25

Start date

2005-10-31

Completion date

2007-07-31

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

Interventions

DRUGIxabepilone

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women aged 20 years or older * Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion criteria

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Design outcomes

Primary

Measure	Time frame
To assess the tumor response using RECIST Criteria to determine the best overall response and response rate	For a maximum of 9 3-week cycles or until unacceptable toxicity

Secondary

Measure	Time frame
To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria	Every cycle
To evaluate the duration of achieved responses	For a maximum of 9 3-week cycles or until unacceptable toxicity
To evaluate time to progression (TTP)	For a maximum of 9 3-week cycles or until unacceptable toxicity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026